Kornimate/medical-research-clean huggingface dataset:
secondary analysis of gut hormones and inflammatory cytokines in fasting subjects

Conditions: Healthy

Summary: the original study executed between 2002-2004 was an interventional trial in which 20, healthy, normal-weight female subjects were randomized to a four-day fast plus daily subcutaneous injections of leptin or a four day fast plus daily subcutaneous injections of a placebo. the primary endpoints were gonadotropin pulsatility, tsh secretion and thyroid function, and cortisol secretion. the current study is a secondary analysis focussed on the placebo group which underwent a four-day fast. the study is looking at the effects of fasting on gut-derived hormones and inflammatory markers in healthy, normal-weight women. the hypothesis for this secondary analysis was that four days of fasting would augment levels of orexigenic gut-derived hormones and suppress levels of anorexigenic gut-derived horomones, while suppressing secretion of inflammatory cytokines.


Eligibility criteria:
inclusion criteria: * female age 18-35 * bmi 20-26.0 * eumenorrheic with normal fsh, tsh, prolactin * hgb \> 12 g/dl, normal creatinine * normal puberty and development * negative pregnancy test. in addition, subjects agreed not to be sexually active during the course of the inpatient study and to use contraception for a period of 48 hours after discharge from the hospital. exclusion criteria: * medical or endocrine problems known to affect thyroid, reproductive, gh or cortisol function * medications known to affect neuroendocrine function * prior history of eating disorder or significant menstrual irregularities * subjects who have a known hypersensitivity to e. coli derived protein. * subjects with a history of seizure disorder, significant cardiac disease, medication for cardiac disease, or kidney disease * history of anaphylaxis or anaphylactoid like reactions.

Keywords: fasting gut hormones inflammatory cytokines
bone mesenchymal stem cell (bmsc) transplantation in liver cirrhosis via portal vein

Conditions: Liver Cirrhosis

Summary: the objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (bmscs) transplantation via portal vein in patients with early and middle stage of liver cirrhosis on the basis of hbv infection. the evaluation of the efficacy includes the level of serum alanine aminotransferase (alt), aspartate aminotransferase(ast), total bilirubin (tb),prothrombin time (pt), albumin (alb), prealbumin(pa), precollagenⅲ(pcⅲ), collagenⅳ(ⅳ-c), laminin(ln), hyaluronidase(hn), liver histological improvement before and 1 week to 1 year after transplantation. child-pugh scores and clinical symptoms were also observed simultaneously.


Eligibility criteria:
inclusion criteria: * aged 18\~60 years. * serum hbsag positive. * ultrasonographic evidences of cirrhosis. exclusion criteria: * history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment. * prothrombin time is less than 30s. * cirrhosis caused by other reasons except hbv infection. * severe problems in other vital organs(e.g.the heart,renal or lungs). * liver tumor on ultrasonography, ct or mri examination. * pregnant or lactating women. * imaging evidences of vascular thromboses.

Keywords: bmsc stem cells liver cirrhosis transplantation
long-term follow-up study of substance abuse screening and intervention in multi primary care centers

Conditions: Substance Use

Summary: the purpose of this research is to improve the ability of primary medical staffs in screening and intervention for alcohol, benzodiazepines, and other illicit drug use.

in order to reduce the social and personal harm caused by drugs, it is urgent to strengthen the ability of the primary health institutions in screening and intervention the addictive substances use. firstly, the investigators will invite 10 primary medical staffs and 10 experts in addition to revise the manual of alcohol, smoking, and substance use involvement screening test (assist) and brief intervention (bi). then, the investigators will recruit related medical staffs in five provinces to participate the training of assist and bi. secondly, the researcher will investigate the effects of bi technology in reducing the use of addictive substances, improve the addiction related knowledge of patients through randomized controlled study. finally, the investigators will collect the research information, revise the manual, and promote the training.

Eligibility criteria:
inclusion criteria: * aged 18-75 years; * the patient to the community medical institutions; * assist score is in 12-27, in a moderate risk; * voluntary to participate; * to agree to complete baseline interviews and follow-up studies exclusion criteria: * unable to complete the questionnaire; * serious physical illness, action inconvenience.

Keywords: screening, brief intervention, and referral to treatment substance use
prevention of intra-uterine adhesions following laparoscopic and laparotomic myomectomy

Conditions: Myoma

Summary: clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy. myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. this study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.

design: double-blind, randomized controlled pilot trial. participant: * age between 18 and 45 years. * intramurale and/or subserosal myoma (figo 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (figo 2-5), who are scheduled for laparoscopic / laparotomic myomectomy. * absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy treatment: application of intrauterine hyalobarrier® gel endo at time of surgery control: no application of hyalobarrier® gel endo follow up: second-look hysteroscopy after 3months to blind all trial participants and gynaecologists doing second-look hysteroscopy, 10 ml of a sterile ultrasound gel will be applied into the vagina at the end of the procedure in all women regardless of their treatment allocation.

Eligibility criteria:
inclusion criteria: * age between 18 and 45 years. * intramurale and/or subserosal myoma (figo 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (figo 2-5), who are scheduled for laparoscopic / laparotomic myomectomy. * absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy exclusion criteria: * pregnancy. * laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy. * presence of endometritis. * other antiadhesion methods

Keywords: postoperative adhesions intrauterine adhesions myomectomy laparoscopic myomectomy laparotomic myomectomy adhesion prevention antiadhesion method
epidural labor analgesia and infant neurobehavior

Conditions: Labor Pain

Summary: infant neurobehavior alteration is predictor of later intelligence development. many factors would influence or are associated with infant neurobehavior, of which exist or appear during perinatal period. neuraxial, especially epidural, analgesia to date is the most effective method in relieving labor pain. although previous studies showed that opioid used in epidural analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation associated manner, whether epidural analgesia itself would produce unpredictable effect on newborn neurobehavior is still unknown. hereby the investigators designed this trial to investigate the hypothesis that epidural analgesia for labor pain control itself would not produce negative effect on infant neurobehavior.


Eligibility criteria:
inclusion criteria: * \>18years and \<45years * spontaneous labor * analgesia request exclusion criteria: * allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records * participants younger than 18 years or older than 45 years * those who were not willing to or could not finish the whole study at any time * using or used in the past 14 days of the monoamine oxidase inhibitors * alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics * subjects with a nonvertex presentation or scheduled induction of labor

Keywords: neurobehavior epidural analgesia local anesthetic opioid
subcutaneous amifostine safety study

Conditions: Head and Neck Cancer; Lung Cancer; Lymphoma

Summary: amifostine is a radioprotective drug which is approved by the us fda for administration prior to each radiation treatment using the intravenous route. the study evaluated the safety of amifostine administered subcutaneously. the four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.


Eligibility criteria:
inclusion criteria: * institutional criteria for administration of amifostine * radiation therapy * ecog ps of at least 2 * no distant mets * granulocyte count greater than 2000 * platelet count greater than 100,000 * creatinine less than 2.0 exclusion criteria: * allergy to amifostine * life expectancy less than 6 mos * investigational drug within last 4 weeks

Keywords: amifostine mucositis nausea hypotension rash
evaluation of amphotericin b in the treatment of biopsy proven candida esophagitis in immunocompromised patients

Conditions: Candidiasis, Esophageal; HIV Infections

Summary: to determine the appropriate duration of amphotericin b therapy for candida esophagitis. to compare the effectiveness of two different amphotericin b doses in the treatment of biopsy-proven candida esophagitis. to determine if low-dose amphotericin b is less toxic than standard dose therapy during a limited treatment period. to evaluate pharmacokinetic and pharmacodynamic parameters of the two different dosing regimens.


Eligibility criteria:
exclusion criteria co-existing condition: patients with histological or clinical (skin rash, cotton wool exudates, candida endophthalmitis, etc.) evidence of disseminated candidiasis are excluded. concurrent medication: excluded: * systemic administration of amphotericin b for a proven or suspected systemic fungal infection. patients with the following are excluded: * documented candida fungemia. * histological or clinical (skin rash, cotton wool exudates, candida endophthalmitis, etc.) evidence of disseminated candidiasis. * systemic administration of amphotericin b for a proven or suspected systemic fungal infection. * patient refusal to enter study. patient must be an immunosuppressed host, with biopsy-proven candida esophagitis. * patients with polymicrobial esophagitis will be included as long as candida esophagitis is documented by esophageal biopsy. * informed consent must be signed and obtained.

Keywords: aids-related opportunistic infections esophagitis acquired immunodeficiency syndrome amphotericin b candidiasis, oral
d-cik combined with chemotherapy for non-small cell lung cancer(nsclc)

Conditions: Lung Cancer; Non-small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with dendritic activated cytokine-induced killer cell (d-cik) for non-small cell lung cancer (nsclc).

60 patients with stage ⅲb～ⅳ nsclc will be randomly divided into group a（receive d-cik treatment and chemotherapy) or group b（just receive chemotherapy),and the randomize ratio will be 1:1. patients in group a will receive 3 cycles of d-cik treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).patients in group b will receive only 4 cycles chemotherapy（every 2 weeks).

Eligibility criteria:
inclusion criteria: * the patient who have singed the informed consent; * histologically confirmed with nsclc at stage ⅲb～ⅳ; * expected survival time is more than 2 month; * eastern cooperative oncology group (ecog) performance status was 0-2. exclusion criteria: * hemoglobin\<8.0 g/dl,white blood cell \<3 x 10\^9/l;platelet count \<75 x 10\^9/l; alt, ast, bun and cr more than normal limits on 3.0 times; * known or suspected allergy to the investigational agent or any agent given in association with this trial; * pregnant or lactating patients; * known history of human immunodeficiency virus (hiv), hepatitis c virus (hcv) or treponemapallidun (tp) infection; * patients who are suffering from serious autoimmune disease; * patients who had used long time or are using immunosuppressant; * patients who had active infection; * patients who are suffering from serious organ dysfunction; * patients who are suffering from other cancer; * other situations that the researchers considered unsuitable for this study.

Keywords: d-cik lung cancer
microvascular reactivity in prepubertal children

Conditions: Child, Only; Obesity; Endothelial Dysfunction

Summary: this is a cross-sectional study aimed to investigate microvascular reactivity in prepubertal children according to adiposity status.

the investigators aimed to investigate microvascular reactivity in prepubertal and to compare these data in different groups according to adiposity status. firstly, the investigators recruited only children from 5 to 10 years at prepubertal status. after excluding those with exclusion criteria and the acceptance (from their parents) to participate in the study, a blood sample was collected and an appointment at biovasc lab was programmed. at this day, participants were subject to nail fold videocapillaroscopy. a method used to investigate microvascular reactivity by a non-invasive mean. after this, participants children were followed to the outpatient's care unit to continue follow-up.

Eligibility criteria:
inclusion criteria: children aged from 5 to 10 years at prepubertal tanner´s status exclusion criteria: * puberty * regular use of any medication * hypertension * heart disease * renal and blood diseases .the presence of any acute or chronic inflammatory/infectious diseases. .presence of diabetes mellitus.
comparison of remimazolam and midazolam for preventing intraoperative nausea and vomiting during cesarean section under spinal anesthesia

Conditions: Pregnancy; Cesarean Section; Spinal Anesthesia

Summary: spinal anesthesia is widely accepted as the anesthetic method of choice for cesarean section. however, high-level blockage or hypotension induced by this technique may induce intraoperative nausea and vomiting (ionv), which is associated with patient discomfort and protrusion of abdominal viscera which may adversely affect patient safety. to prevent ionv, midazolam is frequently administered after delivery, but risk of hypotension and prolonged sedation due to its active metabolite also increases. on the other hand, remimazolam is known to have relatively shorter half-life and less likely induce hypotension when compared to midazolam, yet its effect on ionv has not been thoroughly evaluated. hence, this study aimed to compare the effects of remimazolam and midazolam in preventing ionv in patients scheduled for elective cesarean section.


Eligibility criteria:
inclusion criteria: patients (age ≥ 20yrs and asa class ii or iii) who are scheduled for elective cesarean section exclusion criteria: emergency surgery patients who are diagnosed preeclampsia or eclampsia, bmi ≥ 40kg/m2, iup \< 36 weeks patients with contraindications to spinal anesthesia patients who do not want sedation during the procedure
navigating insurance coverage expansion (nice)

Conditions: HIV/AIDS

Summary: the purpose of this research is to measure the effectiveness of an in-person assistance intervention on successful insurance enrollment, types of insurance coverage, rates of linkage to and retention in hiv-related health care, referrals to other hiv-associated health services, and health outcomes. the study population is black and hispanic men who have sex with men (msm) and transgender persons who are at higher risk for hiv. the study team will be testing the hypotheses that in-person health insurance enrollment assistance results in positive outcomes with regard to linkage to and retention in hiv-related health care. analyses will be used to assess the efficacy of the intervention as an emerging practice.

the overall goal of this study is to test whether providing in-person assistance in enrolling in private health insurance or medicaid for the first time, changing to a different insurance plan, or understanding how to use current insurance policies following hiv testing will (1) increase the proportion of participants who obtain health insurance; (2) result in better health outcomes among participants; (3) improve the linkage and retention rates of participants, especially those diagnosed with hiv; and (4) increase linkage and retention rates sufficiently to justify the cost of implementing the intervention (cost-benefit analysis).

Eligibility criteria:
inclusion criteria: * black or hispanic men who have sex with men (msm) or transgender persons * 18 or older exclusion criteria: * cisgender women * cisgender men who have not had anal or oral sex with a man in last 2 years

Keywords: pre-exposure prophylaxis (prep)
biologics in severe nasal polyposis survey

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: with a prevalence of 2-4% in western countries, chronic rhinosinusitis with nasal polyps (crswnp) is of major concern regarding its substantial impact on the social and physical quality of life. so far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed. during the last 15 years, several studies have shown that crswnp is associated with a t helper 2 (t2) immune response leading to b cell release of ige, mucosal recruitment of eosinophils from bone marrow via interleukin (il)-5, il-4 and il-13 mediated chemoattractant production. new biologic agents capable of blocking t2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with crswnp. in the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies. herein we propose a prospective study monitoring medical records of crswnp patients who undergo biologic treatments. the objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.


Eligibility criteria:
inclusion criteria: * patients of over 18-year old requiring a biologic treatment for crswnp in accordance with its marketing approval exclusion criteria: * oral corticotherapy in the previous month; * biologic treatment with anti-ige (omalizumab), anti-il-5/il-5r (mepolizumab, benralizumab) or anti-il-4/il-13r (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months apart from ongoing biotherapies for severe asthma; * hypersensitivity to humanized antibodies ; * documented sars-cov2 infection in the last 3 months with persistent olfactory disorders related to covid; * pregnant or breast-feeding women; * patient without social coverage

Keywords: biologic nasal polyp chronic rhinosinusitis eosinophil endotype
rollover study of weekly paclitaxel (bms-181339) in patients with advanced or recurrent esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of this study is to provide access to paclitaxel therapy to subjects with advanced or recurrent esophageal cancer who have completed the previous phase 2 study (ca139-540) and who should continue on therapy with paclitaxel as assessed by the treating investigator(s). to evaluate the severity of observed adverse reactions in treated subjects for assessment of long-term safety.


Eligibility criteria:
subjects with advanced or recurrent esophageal cancer who have completed the previous late phase 2 study (ca139-540) and for who continued therapy with paclitaxel would be beneficial as deemed by the investigator(s).
idalopirdine in patients with mild-moderate alzheimer's disease treated with donepezil

Conditions: Alzheimer's Disease

Summary: to establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate alzheimer's disease (ad).

the study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 10 mg/day or 30 mg/day as adjunctive therapy to donepezil 10 mg/day, and a 4-week safety follow-up period following study completion or withdrawal from treatment.

Eligibility criteria:
inclusion criteria: * the patient has a knowledgeable and reliable caregiver. * the patient is an outpatient. * the patient has probable ad. * the patient has mild to moderate ad. * stable treatment with donepezil. * the patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, or be surgically sterile. * the patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, or must have been surgically sterilised prior to the screening visit. exclusion criteria: * the patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than ad. * the patient has a diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) axis i disorder other than ad. * the patient has evidence of clinically significant disease. * the patient's donepezil therapy is likely to be interrupted or discontinued during the study. * the patient is currently receiving memantine or has taken memantine within 2 months prior to screening. other inclusion and exclusion criteria may apply.
tandem dbs for parkinson's disease: a pilot study utilizing stn/gpi + hypothalamic stimulation

Conditions: Parkinson's Disease; Deep Brain Stimulation

Summary: does dual hemispheric stimulation of the subthalamic nucleus (stn) and fornix/hypothalamus potentially improve cognitive function in patients with parkinsons disease.


Eligibility criteria:
inclusion criteria: * all patients will be enrolled from the practice of the primary investigator. * parkinson's disease (pd) patients in whom optimal medical therapy has failed. * all patients will have responsivity to levodopa. * individuals with normal or mild cognitive impairment. exclusion criteria: * clinically significant dementia * other significant neurological or psychiatric disease * previous brain surgery including pallidotomy or thalamotomy * previous placement of other implantable devices
primados study:a study of avastin (bevacizumab) plus docetaxel for first line treatment of patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: this single arm study will assess the efficacy and safety of first line combination treatment with avastin + docetaxel in patients with her2 negative metastatic breast cancer.patients will receive avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). the anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.


Eligibility criteria:
inclusion criteria: * male and female patients, \>=18 years of age; * stage iv, her2 negative metastatic breast cancer; * candidate for taxane-based therapy; * ecog performance status 0-2. exclusion criteria: * prior chemotherapy for metastatic breast cancer; * concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years; * suspicion of cns metastasis; * clinically significant cardiovascular disease.